FDA Audit Outcome: No Findings


The Food and Drug Administration (FDA) conducted an extensive review of IRB documentation for all FDA-related research conducted at UH.

The unannounced, two week audit last November included review of IRB membership, meeting documentation, complete clinical protocols, all IRB SOPs and UH's online system, associated regulatory checklists, and committee communications. The site visit was the first of its kind from the agency.

The audit resulted in no findings. UH received notification from the FDA Office of Science Investigations that UH adheres to all FDA regulations involving the protection of human subjects. 

"I would like to wholeheartedly thank the entire IRB team for their contributions to this successful endeavor and for ensuring the protection of our research subjects each and every day," said Kirstin Holzschuh, executive director for the Research and Integrity Office. "Special kudos go out to Alicia Vargas, who became the point person for the audit. She did a fantastic job aprovided all necessary documentation and clarifications."